Method of using an intravaginal device with fluid transport plates

ABSTRACT

A method of capturing bodily fluid intravaginally providing an intravaginal device that has a fluid storage element having a longitudinal axis and is in fluid communication with at least one fluid transport element. The method involves providing at least one fluid transport element that is bendable about an axis substantially parallel to the longitudinal axis of the fluid storage element and positioned within a human vagina.

CROSS-REFERENCE TO RELATED APPLICATIONS

This invention is related to the following copending applications filedon even date herewith: “Intravaginal Device with Fluid AcquisitionPlates” (U.S. Ser. No. 60/______; Atty Docket No. PPC-5073),“Intravaginal Device with Fluid Acquisition Plates and Method of Making”(U.S. Ser. No. 60/______; Atty Docket No. PPC-5072), “Fluid ManagementDevice with Fluid Transport Element for use within a Body” (U.S. Ser.No. 10/______; Atty Docket No. PPC-5071), “Method of Using IntravaginalDevice with Fluid Transport Plates” (U.S. Ser. No. 10/______; AttyDocket No. PPC-5076), “Tampon with Flexible Panels” (U.S. Ser. No.10/______; Atty Docket No. PPC-5074), and “Intravaginal Device withFluid Acquisition Plates” (U.S. Ser. No.10/______; Atty Docket No.PPC-5070), the content of each of which is incorporated herein.

FIELD OF THE INVENTION

The present invention relates to methods of capturing and storing bodilyfluid intravaginally and devices that may be used for such purposes.More particularly, the present invention relates to a method ofcapturing bodily fluid intravaginally via a fluid transport element andtransporting the bodily fluid to a fluid storage element where the fluidis stored.

BACKGROUND OF THE INVENTION

Devices for capturing and storing bodily fluid intravaginally arecommercially available and known in the literature. Intravaginal tamponsare the most common example of such devices. Commercially availabletampons are generally compressed cylindrical masses of absorbent fibersthat may be over-wrapped with an absorbent or nonabsorbent cover layer.

The tampon is inserted into the human vagina and retained there for atime for the purpose of capturing and storing intravaginal bodilyfluids, most commonly menstrual fluid. As intravaginal bodily fluidcontacts the tampon, it should be absorbed and retained by the absorbentmaterial of the tampon. After a time, the tampon and its retained fluidis removed and disposed, and if necessary, another tampon is inserted.

A drawback often encountered with commercially available tampons is thetendency toward premature failure, which may be defined as bodily fluidleakage from the vagina while the tampon is in place, and before thetampon is completely saturated with the bodily fluid. The patent arttypically describes a problem believed to occur that an unexpanded,compressed tampon is unable to immediately absorb fluid. Therefore, itpresumes that premature leakage may occur when bodily fluid contacts aportion of the compressed tampon, and the fluid is not readily absorbed.The bodily fluid may bypass the tampon.

To overcome this problem of premature leakage, extra elements have beenincorporated into a basic tampon to try to direct and control the flowof fluid toward the absorbent core.

For example, U.S. Pat. No. 4,212,301 (Johnson) discloses a unitaryconstructed digital tampon having a lower portion compressed preferablyin the radial direction to form a rigid, rod-like element, whichprovides a central rigidified elongated core and an upper portion leftsubstantially uncompressed. After insertion, the uncompressed portionmay be manipulated to contact the vaginal wall to provide an immediateseal against side leakage. The uncompressed portion allows for highabsorbent capacity immediately upon insertion. While this tampon mayallow for a certain amount of protection from bypass leakage, theuncompressed portion may become saturated before the compressed portionhas a chance to expand and become absorbent.

U.S. Pat. No. 6,358,235 (Osborn et al.) discloses a “hollow” bag-liketampon that may have an interior projection made from highly compressedabsorbent material. The interior projection is preferably attached tothe inside surface of the head of the tampon. The hollow tampon portionmay include at least one pleat in the absorbent outer surface and issoft and conformable. The tampon is not pre-compressed to the pointwhere the fibers temporarily “set” and re-expand upon the absorption offluid. The absorbent portions of the tampon can saturate locally, whichleads to bypass leakage.

U.S. Pat. No. 6,177,608 (Weinstrauch) discloses a tampon having nonwovenbarrier strips which are outwardly spreadable from the tampon surface toreliably close the free spaces believed to exist within a vaginalcavity. The nonwoven barrier strips extend about the tampon in acircumferential direction at the surface or in a helical configurationabout the tampon and purportedly conduct menstrual fluid toward thetampon surface. The nonwoven barrier strips are attached to the cover bymeans of gluing, heat sealing, needle punching, embossing or the likeand form pleats. The nonwoven barrier strips are attached to the tamponblank and the blank is embossed, forming grooves extending in alongitudinal direction. While this tampon purports to direct fluid tothe core, it attempts to achieve this by forming pockets of absorbentnonwoven fabric. In order to function, it appears that these pocketswould have to be opened during use to allow fluid to enter. However,based upon current understandings of vaginal pressures, it is notunderstood how the described structure could form such an opened volume.

U.S. Pat. No. 6,206,867 (Osborn) suggests that a desirable tampon has atleast a portion of which is dry expanding to cover a significant portionof the vaginal interior immediately upon deployment. To address thisdesire, it discloses a tampon having a compressed central absorbent corehaving at least one flexible panel attached along a portion of the sidesurface of the core. The flexible panel appears to provide the“dry-expanding” function, and it extends outwardly from the core awayfrom the point of attachment. The flexible panel contacts the innersurfaces of the vagina when the tampon is in place and purportedlydirects fluid toward the absorbent core. The flexible panel is typicallyattached to the pledget prior to compression of the pledget to form theabsorbent core and remains in an uncompressed state.

U.S. Pat. No.5,817,077 (Foley et al.) discloses a method of preservingnatural moisture of vaginal epithelial tissue while a using a tamponwhere the tampon has an initial capillary suction pressure at the outersurface of less than about 40 mm Hg. This allows the tampon to absorbvaginal secretions without substantially drying the vaginal epithelialtissue. The multiple cover layers can be used to increase the thicknessof the cover material. While this represents a significant advancementin the art, this invention does not address by-pass leakage.

Additionally, U.S. Pat. No. 5,545,155 (Hseih et al.) discloses anexternal absorbent article that has a set of plates separated by spacerelements. The plates may be treated to affect wettability so that fluidwill flow easily across the surface. Extending through the upper plateis a plurality of openings, which allow fluid to flow with littlerestriction into the space between the upper and lower plates. When thefluid flows downward in the z-direction from the upper plate to thelower plate, it will then flow laterally in the x- and y-directions.Therefore, an external absorbent article can contain fluid gushes, butit does not appear to address the problems relating in particular tointravaginal devices, such as a tampon.

Still others have created density differences within the absorbentstructure of the tampon to try to encourage fluid transport within thetampon's absorbent structure. These density differences may allow thetampon to absorb somewhat more fluid, but premature leakage stilloccurs.

A further attempt to solve the problem of premature tampon leakage hasbeen to create holes of different sizes within the tampon cover. Theareas with the larger holes may absorb more fluid, but the areas withthe smaller holes are limited in the amount of fluid that they canabsorb, and premature leakage may still occur.

While the prior art is replete with examples of sanitary protectionarticles that capture bodily fluids both externally and intravaginally,these examples do not overcome the problem of premature failure oftenidentified as by-pass leakage that commonly occurs while using internalsanitary protection devices. Many solutions to this problem haveinvolved increasing the rate of expansion of a highly compressedabsorbent article.

Therefore, a need exists for a method of capturing and storingintravaginal bodily fluid in such a manner that reduces prematureleakage and utilizes the absorbent capacity of an intravaginal absorbentdevice.

SUMMARY OF THE INVENTION

It has been discovered that intravaginal bodily fluid may be capturedand stored intravaginally in such a manner that reduces prematureleakage of and utilizes the absorbent capacity of an intravaginalabsorbent device.

In one aspect of the invention, a method is described for capturingbodily fluid intravaginally. The method involves providing at least onefluid transport element in fluid communication with the fluid storageelement and positioned within a human vagina, the fluid transportelement being bendable about an axis substantially parallel to thelongitudinal axis of the fluid storage element and the fluid transportelement being positioned within a human vagina. The fluid transportelement has:

-   -   a. a first plate with an outwardly oriented surface and an        inwardly oriented surface; and    -   b. a second plate with a first surface disposed in facing        relationship with the inwardly oriented surface of the first        plate, and an opposite surface.

The second plate is sufficiently spaced apart from the first plate toprovide inter-plate capillary action between the first and secondplates. The transport element is positioned within the vagina such thatthe outwardly oriented surface of the first plate and the oppositesurface of the second plate contact the vaginal walls. Intravaginalbodily fluid is exposed to the transport element and is transportedbetween the first plate and the second plate by inter-plate capillaryaction to the fluid storage element, where the fluid is stored.

In another aspect of the invention, a method is described for storingbodily fluid intravaginally. The method involves providing a fluidstorage element in fluid communication with a fluid transport element,with the fluid transport element being positioned within a human vaginaand being bendable about an axis substantially parallel to thelongitudinal axis of the fluid storage element. The fluid transportelement has:

-   -   a. a first plate with an outwardly oriented surface and an        inwardly oriented surface; and    -   b. a second plate with a first surface disposed in facing        relationship with the inwardly oriented surface of the first        plate, and an opposite surface.

The second plate is sufficiently spaced apart from the first plate toprovide inter-plate capillary action between the first and secondplates. The transport element is positioned within the vagina such thatthe outwardly oriented surface of the first plate and the oppositesurface of the second plate contact the vagina. Bodily fluid within thehuman vagina is exposed to the fluid transport element and istransported between the first plate and the second plate by inter-platecapillary action to the fluid storage element, where the fluid isstored.

Other aspects and features of the present invention will become apparentto those ordinarily skilled in the art upon review of the followingdescription of specific embodiments of the invention in conjunction withthe accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 a shows a side elevation of an intravaginal device having a pairof fluid transport elements formed as extensions of a cover.

FIG. 1 b shows a transverse cross-section of the device in la along line1 b-1 b.

FIG. 1 c shows the transverse cross-section shown in 1 b, after theintroduction of a fluid between the plates of the fluid transportelement.

FIGS. 2 a-c show enlarged cross-sections of alternate embodiments offluid transport elements of the present invention formed of polymericapertured formed film having differing orientations of the formed filmplates.

FIG. 3 shows an enlarged cross-section of an alternate embodiment of afluid transport element of the present invention having nubbles toseparate a set of film plates.

FIGS. 4 a-c show various aspects and orientations of an intravaginaldevice of the present invention.

FIG. 5 shows a transverse cross-section of a human vagina with a tamponaccording to FIG. 4 b disposed therein with one fluid transport elementextending away from the fluid storage element.

FIG. 6 shows a transverse cross-section of a human vagina with a tamponaccording to FIG. 4 b disposed therein with the fluid transport elementsremaining wrapped around the fluid storage element.

FIG. 7 shows a side view of a preconstruction of the tampon embodimentof FIG. 4 a.

FIG. 8 shows an embodiment of the present invention disposed within anapplicator.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As used herein in the Specification and the Claims, the term “bodilyfluid” and variants thereof mean bodily exudates, especially liquidsthat are produced by, secreted by, emanate from, and/or discharged froma human body.

As used herein in the Specification and the Claims, the term “fluids”and variants thereof relate to liquids, and especially bodily fluids.

As used herein in the Specification and the Claims, the term “sheet” andvariants thereof relate to a portion of something that is thin incomparison to its length and breadth.

As used herein in the Specification and the Claims, the term “parallelplate” and variants thereof relate to a system of at least tworelatively parallel sheets that are capable of moving fluids throughinter-plate capillary action. The individual “plates” in the system maybe flexible and/or resilient in order to move within their environment.However, they may be maintained in a substantially facing relationshipwith relatively constant separation at least in a localized portion oftheir structure (as compared with their relative length and width).Thus, two sheets could be fluted, but if the flutes are “nested”, thesheets would generally remain generally parallel in any given localizedportion.

As used herein in the Specification and the Claims, the term“inter-plate capillary action” and variants thereof mean the movement offluid due to a pressure difference across a liquid-air meniscus createdwithin a gap between two substantially parallel plates. The two platesneed not be held apart a specific distance, although they should beseparable to allow fluid to move between them by inter-plate capillaryaction. A general equation providing the rise of a fluid betweenparallel plates is reported as:$h = \frac{2\sigma^{*}\cos\quad\theta}{\rho^{*}g^{*}d}$

-   -   in which:    -   h is rise of fluid between plates    -   σ is the surface tension of fluid in contact w/plate    -   θ is contact angle    -   ρ is density    -   d is distance between plates, and    -   g is the gravitational constant

Therefore, as long as the contact angle, θ, is less than 90°, there willbe some capillary attraction.

As used herein in the Specification and the Claims, the term “porousmedium” and variants thereof relates to a connected 3-dimensional solidmatrix with a highly ramified network of pores and pore throats in whichfluids may flow.

As used herein, the term “separable plates” and variants thereof meanany condition of separation of the first plate and the second plate,which allows fluid to move between the plates. This includes situationsin which facing surfaces of adjacent first and second plates aretouching one another in portions of or across substantially all of theirfacing surfaces. This also includes situations in which the facingsurfaces of the adjacent first and second plates are separably joinedtogether such that upon contact with fluid, the surfaces separate enoughto provide for fluid to move between them. This further includessituations in which facing surfaces of adjacent first and second platesare joined together, as long as fluid may still move freely between thesurfaces.

As used herein in the Specification and the Claims, the term “in fluidcommunication” and variants thereof relate to elements that are arrangedand configured to allow fluid to move therebetween. The fluid movementmay be by interfiber capillary movement, intrafiber capillary movement,osmotic pressure, inter-plate capillary action, mechanical channeling,and the like.

As used herein in the Specification and the Claims, the term “coupled”and variants thereof relate to the relationship between two portions ofan integral structure that are either portions of the same material(e.g., two portions of a folded sheet) or are materials that are joinedtogether (e.g., two separate sheets that are bonded together).

As used herein in the Specification and the Claims, the term“fluid-permeable cover” and variants thereof relates to materials thatcover or enclose surfaces of the device and reduce the ability ofportions (e.g., fibers and the like) from becoming separated of thedevice and left behind upon removal. The term and variants thereofinclude, without limitation, sheet-like materials, such as aperturedfilms and woven and non-woven fibrous webs, surface treatments, such ascoatings or cover layers of integrating materials, such as binders andthermobondable fibers, and the like.

In one aspect, this invention relates to a method for the intravaginalcapture and storage of bodily fluids by providing a fluid storageelement and a fluid transport element. In one embodiment, the fluidstorage element and the fluid transport element are provided in the formof a tampon.

Referring to FIG. 1 a-1 c, this invention provides an intravaginaldevice 10 having at least one fluid transport element 12 in fluidcommunication with a fluid storage element 14 (FIGS. 1 a-1 c show twofluid transport elements 12 located on opposite sides of the fluidstorage element 14). The device may also include a withdrawal mechanism,such as a string 16. The fluid transport element has at least a firstplate 18 and a second plate 20. The first and second plates combine toprovide a set of parallel plates, and the fluid transport elements 12are shown as extending radially away from the fluid storage element 14.Additional plates may also be incorporated into each fluid transportelement 12.

The plates are configured and arranged to allow the introduction ofbodily fluid 22 to separate a plate from adjacent plate(s) (FIG. 1 c).At least one opening 24 allows the introduction of bodily fluids 22.Optionally, one or more spacer elements 26 can be inserted to establishand to maintain space between adjacent plates.

FIG. 1 b shows a pair of parallel plates prior to the introduction of afluid. In this view, the facing surfaces of the adjacent plates 18, 20are in contact. On the other hand, FIG. 1 c shows the set of parallelplates separated by a bodily fluid 22, providing an inter-platecapillary gap 28 between the inwardly oriented surface 30 of the firstplate 18 and the first surface 32 of the second plate 20. Thisinter-plate capillary gap 28 is sufficient to provide inter-platecapillary action to allow the fluid transport element 12 to acquire, tospread, and to move bodily fluids 22 from the vagina to the fluidstorage element 14. The first plate 18 also has an outwardly orientedsurface 34, and the second plate 20 also has an opposite surface 36.

The plates 18, 20 can be made of almost any hydrophobic or hydrophilicmaterial, preferably sheet-like. The thickness of each plate is notcritical. However, it can preferably be selected from the range of fromabout 0.005 to about 0.050 inch. The materials of construction and thethickness of the plates should be designed so that they are sufficientlystiff and/or resistant to wet collapse when exposed to fluid.

In particular, materials useful for forming the fluid transport elementmay have properties such as thermobondability to provide means toincorporate it into the intravaginal device. A representative,non-limiting list of useful materials includes polyolefins, such aspolypropylene and polyethylene; polyolefin copolymers, such asethylenevinyl acetate (“EVA”), ethylene-propylene, ethyleneacrylates,and ethylene-acrylic acid and salts thereof; halogenated polymers;polyesters and polyester copolymers; polyamides and polyamidecopolymers; polyurethanes and polyurethane copolymers; polystyrenes andpolystyrene copolymers; and the like. The fluid transport element mayalso be micro-embossed or apertured. Examples of films having aperturesinclude for example, three-dimensional apertured films, as disclosed inThompson, U.S. Pat. No. 3,929,135, and Turi et al, U.S. Pat. No.5,567,376, as well as two-dimensional reticulated film, such as thatdescribed in Kelly, U.S. Pat. No. 4,381,326. FIGS. 2 a-2 c illustratethree combinations of the apertured film of Thompson.

It may be helpful to keep the exposed surface of the fluid transportelement as smooth as possible. It may also be helpful to provide it witha low coefficient of friction. These characteristics may provide atleast two benefits: (1) the force required to insert the intravaginaldevice is reduced, and (2) it reduces the damage otherwise caused byscraping of soft, tender vaginal tissue during insertion, wearing andremoval. Plates 18 and 20 may be made from the same material oralternately, plate 18 may be made from a different material than plate20.

The parallel plates can have any physical structure to provide aresistance to fluid flow vector in the direction parallel to theinwardly oriented surface 30 of the first plate 18 and the first surface32 of the second plate 20 that is less than the resistance to fluid flowvector in the direction perpendicular to the plates. Preferably, theplates are made from any smooth material with a non-fibrous surface.Suitable materials include, without limitation, foil, waxed sheets,film, apertured film, etc. Each plate does not need to be made of thesame material as its corresponding parallel plate. For instance thefirst plate 18 could be an apertured film to allow fluid to enter andthe second plate 20 could be a solid film to move fluid to the storageelement. Of course, the parallel plates must be able to transport fluidbetween the two layers.

The fluid transport element 12 should be strong enough to preventrupturing during handling, insertion, and removal and to withstandvaginal pressures during use.

It is preferable that the surface of at least one of the plates of thefluid transport element 12 be sufficiently wettable by the bodily fluidsthat the intravaginal device 10 is intended to collect (this resultslargely from a correlation of the surface energy of the plate surfaceand the bodily fluid(s)). Thus, the bodily fluid will easily wet theplate, and capillarity between the plates will draw these bodily fluidsfrom a source to a fluid storage element that is in fluid communicationwith the fluid transport element.

Surface treatments can be used to modify the surface energy of theplates 18, 20. In a preferred embodiment a surfactant is applied toincrease the wettability of the outer or inner surfaces of the parallelplates. This will increase the rate at which the bodily fluids are drawninto and spread between a pair of plates. The surfactant can be applieduniformly to either the inner or outer surfaces or it could be appliedwith varying coating weights in different regions.

A useful measure to determine the wettability of a plate surface is itscontact angle with 1.0% saline. Preferably, the contact angle with 1.0%saline is less than about 90 degrees.

In order to accomplish this, the materials of plates can be chosen fromthose materials that are known in the art to have low energy surfaces.It is also possible and useful to coat materials with high-energysurfaces with a surface additive, such as a non-ionic surfactant (e.g.,ethoxylates), a diol, or mixtures thereof, in order to increase theirwettability by bodily fluids. Such additives are well known in the art,and examples include those described in Yang et al., U.S. applicationNo. 2002-0123731-A1, and U.S. Pat. No. 6,570,055. Other means ofincreasing wettability can also be used, such as by corona dischargetreatment of, for example, polyethylene or polypropylene, or by causticetching of, for example, polyester.

The parallel plates forming the fluid transport element can be of anyflexibility as long as the material is able to transport fluid to thefluid storage element while the device is in use. It is also preferablethat the fluid transport element be sufficiently flexible to provide theuser with comfort while inserting, wearing and removing the device.

The surfaces of the first and second plates facing each other can have avariety of surface textures, ranging from smooth to highly textured. Thetexturing element may be included as a spacer 26.

The desire to include spacers 26 or texture may be based on thematerial's ability to withstand wet collapse when simultaneouslysubjected to compressive forces and fluid.

The spacer elements 26 can be separate elements applied to one or moreof the plates, or they can be integral portions of a plate that extendaway from one of the plate's major surfaces. A representative list ofsuch separate spacer elements includes, without limitation, foamedmaterials such as polystyrene foam; particles such as beads andcrystals; discontinuous material such as netting, thread, wax, adhesive,any discrete element that causes a separation between the plates and thelike.

Integral spacer elements can be thickened portions of the plate materialor deformations of the plate material. A representative list of such anintegral spacer element includes, without limitation, nubbles,embossments, corrugations, deformations, and the like. Included in thisdefinition are surface treatments that permanently bond a secondarymaterial to a surface of a first. One example of a deformation isprovided as the sidewalls 38 of a “three-dimensional” polymericapertured formed film material shown in FIGS. 2 a-2 c. First and secondplates 18, 20 made from apertured formed film with the sidewalls 38facing each other as the inward surface 30 of the first plate 18 and thefirst surface 32 of the second plate 20 can be used to increase thetexture in order to break up the viscosity of the fluid beingtransported. The texture can also be in a gradient. For example, in oneembodiment, the texture of the plates has a gradient from smooth nearthe edge of the plates where the fluid enters the fluid transportelement to more textured where the fluid is absorbed.

In another example, shown in FIG. 3, the spacer elements are nubbles 40extending from the inward surface 30 of the first plate 18 and restingon the first surface 32 of the second plate 20.

In order to maintain stability against sliding of the plates withrespect to each other and changing of the space between them, it isacceptable, and may be preferable, to secure some local areas of contactbetween the spacer elements 26 and the adjacent plate or even betweenspacer elements 26 of two adjacent plates. The plates may be securedthrough means known to those of ordinary skill in the art. Arepresentative list of such securing means includes, without limitation,thermobonding, adhering, crimping, embossing, ultrasonic bonding orwelding, and the like. The adhesive may be applied between the spacerelements and the first and second plates. Preferably, the adhesive iswettable.

The at least one opening can be at the edge of the plates, e.g., edgesof adjacent plates are separated or plates themselves may have at leastone opening. The openings need not be uniform. For example, one openingmay be located at the edge of the plates and a plurality of smalleropenings or apertures can be distributed throughout one or more plate.Preferably, each plate has plurality of openings distributed throughout.An example of openings distributed throughout is an apertured film. Thedistribution can be uniform or arranged to provide regions of higheropen area and regions of lower open area.

A plurality of openings or apertures 42 may extend through at least oneof the first and second plates 18, 20. These apertures 42 may extendcompletely through the plate and may be present in both of the plates.The apertures 42 allow fluid that contacts the outward surface 34 of thefirst plate 18 or the opposite surface 36 of the second plate 20 to flowinto the inter-plate capillary gap 28 between the plates with as littlerestriction as possible. In the example of apertured film, it ispreferred that the total surface area of the plate occupied by theopenings is from about 5% to preferably about 50%. More preferably, itwill be from about 25% to about 45%. Having this much open area formedin a plate will allow fluid that is deposited on that plate to easilyflow into the inter-plate capillary gap 28.

It is preferable that any individual opening (e.g., edge opening 24 offluid transport element 12 or aperture 42) is large enough to easilypass any highly viscous material, including menstrual fluid. While thegeometry of the openings is not critical, the opening 24, 42 should besized sufficient to allow easy passage of non-absorbable material. Ifthe apertures 42 are not circular, then the measurement should be madeacross the narrowest part of the opening, which would be mostrestrictive to the flow of non-absorbable material.

In the example of unapertured film that has an opening 24 at the ends ofthe plates 18, 20, the size of the opening 24 is a result of the fluid'sability to separate the plates.

It is preferred that the apertures 42 are large enough to let viscousfluid pass through but not too large to create too rough of a surface asto compromise the wearer's comfort. A preferred aperture 42 is circularand is between 10 mils and 40 mils in diameter. Most preferably it isbetween 18 mils and 27 mils.

Open area may be determined by using image analysis to measure therelative percentages of apertured and unapertured, or land, areas.Essentially image analysis converts an optical image from a lightmicroscope into an electronic signal suitable for processing. Anelectronic beam scans the image, line-by-line. As each line is scanned,an output signal changes according to illumination. White areas producea relatively high voltage and black areas a relatively low voltage. Animage of the apertured formed film is produced and, in that image, theholes are white, while the solid areas of thermoplastic material are atvarious levels of gray. The more dense the solid area, the darker thegray area produced. Each line of the image that is measured is dividedinto sampling points or pixels. The following equipment can be used tocarry out the analysis described above: a Quantimet Q520 Image Analyzer(with v. 5.02B software and Grey Store Option), sold by LEICA/CambridgeInstruments Ltd., in conjunction with an Olympus SZH Microscope with atransmitted light base, a plan 1.0× objective, and a 2.50× eyepiece. Theimage can be produced with a DAGE MTI CCD72 video camera.

A representative piece of each material to be analyzed is placed on themicroscope stage and sharply imaged on the video screen at a microscopezoom setting of 10×. The open area is determined from field measurementsof representative areas. The Quantimet program output reports mean valueand standard deviation for each sample.

Referring to FIGS. 4 a-4 c, the first and second plates 18, 20 may beseparate elements (i.e, adjacent to each other but not necessarilyjoined) or they may be extensions of the same sheet-like material, e.g.,formed by a fold in a sheet of material. In such a folded embodiment,the material is folded to form a pleat with the first and second platesfacing each other.

FIG. 4 a-4 c shows one embodiment of a tampon 10 that may be used in themethod of this invention. The tampon has a fluid storage element 14 anda fluid transport element 12. The fluid transport element has a firstplate 18 and a second plate 20. The first plate 18 has an outwardlyoriented surface 34 and an inwardly oriented surface 30. The secondplate 20 has a first surface 32 disposed in facing relationship with theinwardly oriented surface 30, and an opposite surface 36.

A preferred embodiment with pleats is shown in FIGS. 4 a-4 c, where thepleats 44 are folds in a fluid-permeable cover material 46. The pleats44 create plates that are bendable about an infinite number of bendingaxes (b_(1-i)-b_(1-i)) that are substantially parallel to thelongitudinal axis (X-X) of the product, which longitudinal axis extendsthrough the insertion end 48 and withdrawal end 50. These bending axesallow the plates to wrap around the product, either partially orcompletely. One such bending axis (b₁-b₁) is shown in FIG. 4 a.

The fluid transport element 12 is in fluid communication with the fluidstorage element 14 and directs fluid from the vagina to the storageelement 14. Generally, fluid will be directed from each fluid transportelement 12 to a particular region of the fluid storage elementassociated with that fluid transport element. Thus, if the device hasonly one fluid transport element 12, the fluid will contact the fluidstorage element in one interface 52.

Therefore, additional fluid transport elements 12 directing fluid toadditional locations of the fluid storage element 14 will improve theefficient usage of the fluid storage element 14. For example, two fluidtransport elements 12 could be directed to opposite sides of the fluidstorage element 14, as shown in FIGS. 1 a-1 c. Each additional fluidstorage element 12 can direct fluid to additional interface locations 52of the fluid storage element 14. For example, four evenly spaced fluidtransport elements 12 allow fluid to be directed to each quarter of thefluid storage element 14 surface as shown in FIGS. 4 a-c. Five or moreelements would provide even more direct access. This can allow the fluidto contact the fluid storage element 14 uniformly and help to prevent orreduce local saturation of the fluid storage element 14.

While the above description provides for direct fluid communicationbetween a fluid transport element 12 and the fluid storage element 14,direct fluid contact is not necessary. There can be fluid communicationthrough an intermediate element, such as a porous medium (e.g., a foamor fibrous structure), a hollow tube, and the like.

Enlarging the area of the interface 52 between the fluid transportelement 12 and fluid storage element 14 can also help to maximize thefluid communication.

For example, elongating the interface by increasing the length of thefluid transport element 12 allows more fluid to flow into the fluidstorage element 14.

The fluid transport element 12 may extend in any orientation from thesurface of the fluid storage element 14. It is not necessary for thefluid transport element to be on the surface of the fluid storageelement.

The inter-plate capillary gap 28 formed by the first and second platescan terminate at the interface 52 or can extend into and/or through thefluid storage element 14. The parallel plates can have additional layerson top of them as long as these additional layers allow fluid to enterthe plates. The parallel plates can end at the boundary of the transportelement or can extend into it the fluid storage element.

The fluid transport element 12 may be formed to extend from the surfaceof the fluid storage element 14 as in FIGS. 1 a-1 c. It can be made inany convenient shape, including semicircular, triangular, square,hourglass etc. Additionally the two plates of the element do not have tobe completely coextensive, as long as they are at least partially in afacing relationship. In an alternative embodiment, the withdrawal string16 could be replaced by a pair or another combination of ribbon-likeparallel plates (not shown).

Parallel plates can be held in close proximity to the storage element ina variety of ways including directly or indirectly via an additionalelement to the storage element. A variety of methods can be used toattach the fluid transport element 12 including but not limited to heat,adhesive, ultrasonics, sewing, and mechanically engaging the fluidstorage element 14. In one embodiment, the fluid transport element isheat sealed to the fluid storage element (not shown).

The fluid transport element(s) 12 can be attached at the sides,insertion end 48, and/or withdrawal end 50 of the intravaginal device.Additionally, the fluid transport element(s) 12 may be attached tothemselves and not to the storage element as in a parallel plates bagtype covering of the storage element. The parallel plates could also beattached to the withdrawal string. These and other means of attachmentare disclosed in the commonly-assigned, copending patent applicationsentitled “Intravaginal Device with Fluid Acquisition Plates” (U.S. Ser.No. 60/______; Atty Docket No. PPC-5073), “intravaginal Device withFluid Acquisition Plates and Method of Making” (U.S. Ser. No. 60/______;Atty Docket No. PPC-5072), both filed on even date herewith, thecontents of which are herein incorporated by reference.

During use, fluid transport element(s) 12 can take on manyconfigurations within the vagina. For example, a fluid transport element12 may extend into the vagina away from the fluid storage element 14, asshown in FIG. 5. Alternatively, and the fluid transport element(s) 12may remain wound about the fluid storage element 14, contacting thevaginal surfaces only through the outwardly oriented surface 34 (FIG.6).

The fluid storage element can be any convenient shape includingcylindrical, cup like, hourglass, spherical, etc. It can be an absorbentor a fluid collection device. It can also be in separate sections withthe fluid transport element(s) 12 bridging or connecting the sections(not shown).

The fluid storage element can be made of any composition known in theart, such as compressed fibrous webs, rolled goods, foam etc. Thestorage element can be made of any material known in the art such ascotton, rayon, polyester, superabsorbent material, etc.

In one preferred embodiment, the fluid storage element 14 is anabsorbent tampon. Absorbent tampons are usually substantiallycylindrical masses of compressed absorbent material having a centralaxis and a radius that defines the outer circumferential surface of thetampon. Such tampons are disclosed in e.g., Haas, U.S. Pat. No.1,926,900; Dostal, U.S. Pat. No. 3,811,445; Wolff, U.S. Pat. No.3,422,496; Friese et al., U.S. Pat. No. 6,310,296; Leutwyler et al.,U.S. Pat. No. 5,911,712, Truman, U.S. Pat. No. 3,983,875; and Agyaponget al., U.S. Pat. No. 6,554,814. Tampons also usually include afluid-permeable cover (which may include or be replaced by anothersurface treatment) and a withdrawal string or other removal mechanism.

Absorbent materials useful in the formation of the absorbent bodyinclude fiber, foam, superabsorbent, hydrogels, and the like. Preferredabsorbent material for the present invention includes foam and fiber.Absorbent foams may include hydrophilic foams, foams that are readilywetted by aqueous fluids as well as foams in which the cell walls thatform the foam themselves absorb fluid.

Fibers may be selected from cellulosic fiber, including natural fibers(such as cotton, wood pulp, jute, and the like) and synthetic fibers(such as regenerated cellulose, cellulose nitrate, cellulose acetate,rayon, polyester, polyvinyl alcohol, polyolefin, polyamine, polyamide,polyacrylonitrile, and the like).

The fluid storage element may also be in the form of a collection cup.Examples of such devices are disclosed in Zoller, U.S. Pat. No.3,845,766 and Contente et al., U.S. Pat. No. 5,295,984. Collectiondevices are designed to assume a normally open, concave configuration,with an open side facing a user's cervix. The collection devices may befolded, or otherwise manipulated, to facilitate insertion into thevaginal canal

With reference to FIG. 7, the pre-construction of the exemplary tampon,a square sheet 56 of apertured film is centered on the insertion end 48of the fluid storage member 14. The corners A, B, C, and D of the sheetof apertured film are then folded down along the sides of the fluidstorage element and fastened to the fluid storage element in an areaproximal to the withdrawal end 50 of the fluid storage element.

The resulting tampon, as illustrated in FIG. 4 a, has four fluidacquisition elements extending outwardly from the sides of the fluidstorage member. Each of the fluid acquisition elements comprises a firstplate and a second plate comprising the apertured film describedhereinbefore.

Before the tampon is used, the fluid transport elements 12 may bewrapped around the fluid storage element, as illustrated in FIG. 4 b,and packaged. This wrapping presents the tampon in a compactconfiguration suitable for insertion into a human vagina. The insertionmay be manually, that is, without the use of an applicator. Alternately,the compact configuration shown in FIG. 4 b may be placed and packagedwithin an applicator. An example of this configuration is shown in FIG.8. Intravaginal device 10 has been formed and placed within theinsertion portion of a cylindrically shaped applicator 56.

After a desired period of time, the tampon with its captured and storedbodily fluid is removed by the user and disposed. A second, similartampon assembly may then be inserted to capture and store additionalfluid in the same manner.

In some further detail, the invention provides a method of using aplurality of tampons during a period of menstruation. The user canobtain an intravaginal device, such as a tampon, as describedhereinabove. She can position a first tampon within her vaginal canalwhile maintaining at least a portion of a major surface of the fluidtransport element in contact with at least a portion of an outer surfaceof the fluid storage element. The tampon can be left to collect a firstvolume of vaginal discharge while holding the first tampon in position.She can then remove the first tampon and subsequently dispose of it. Theuser can then obtain a second, similar tampon to replace the first.These steps are performed during a woman's period of menstruation, andthey can be repeated as often as necessary.

During the insertion of the tampon, the user may choose to manipulatethe tampon to unwrap or allow a distal portion of the at least one fluidtransport element from the outer surface of the fluid storage element.In this manner, the outwardly oriented surface of the first plate andthe opposite surface of the second plate may both contact the vaginalwalls “W”, as shown in FIG. 5. Alternately, the user may insert thetampon without significantly disturbing the at least one fluid transportelement, and the element will more likely remain as it was packaged. Forexample, a tampon having a convolutedly wrapped fluid transport elementmay leave it in that position, as shown in FIG. 6.

In this invention, the intravaginal device can be used to capture orstore bodily fluid. In particular, a method is provided for a capturingbodily fluid management device having a fluid transport element that isbendable about an axis substantially parallel to the longitudinal axisof the fluid storage element, the fluid transport element having—a firstplate having an outwardly oriented surface and an inwardly orientedsurface; a second plate having a first surface disposed in facingrelationship with the inwardly oriented surface of the first plate andan opposite surface, and sufficiently spaced apart from the first plateto provide inter-plate capillary action between the first plate and thesecond plate; the acquisition element being positioned within the vaginasuch that the outwardly oriented surface of the first plate and theopposite surface of the second plate contact the vaginal walls; wherebybodily fluid within the human vagina is exposed to the liquidacquisition element and is captured and transported between the firstplate and the second plate by inter-plate capillary action to the liquidstorage element where the fluid is stored.

The specification and embodiments above are presented to aid in thecomplete and non-limiting understanding of the invention disclosedherein. Since many variations and embodiments of the invention can bemade without departing from its spirit and scope, the invention residesin the claims hereinafter appended.

1. A method of capturing intravaginal bodily fluid, the method comprising the steps of: a) providing a fluid storage element having a longitudinal axis; b) providing at least one fluid transport element in fluid communication with the fluid storage element and positioned within a human vagina, the at least one fluid transport element bendable about an axis substantially parallel to the longitudinal axis of the fluid storage element, the fluid transport element comprising: i) a first plate having an outwardly oriented surface and an inwardly oriented surface; and ii) a second plate having a first surface disposed in facing relationship with the inwardly oriented surface of the first plate, and an opposite surface, and sufficiently spaced apart from the first plate to provide inter-plate capillary action between the first plate and the second plate; wherein the at least one fluid transport element is positioned within the vagina such that the outwardly oriented surface of the first plate and the opposite surface of the second plate contact the vaginal walls, whereby bodily fluid within the human vagina is exposed to the at least one fluid transport element and is transported between the first plate and the second plate by inter-plate capillary action to the fluid storage element where the fluid is stored.
 2. The method of claim 1, wherein at least one of the first and second plates comprises an apertured polymeric film.
 3. The method of claim 2, wherein the first and second plates are formed of a folded sheet of apertured polymeric film.
 4. A method of using a plurality of tampons during a period of menstruation, the method comprising the steps of: a) providing a first tampon comprising: i) at least one fluid transport element comprising: A) a first plate having an outwardly oriented surface and an inwardly oriented surface; B) a second plate coupled to the first plate that is capable of separating from the first plate sufficiently to provide inter-plate capillary action, the second plate having a first surface disposed and maintained in facing relationship with the inwardly oriented surface of the first plate and an opposite surface; and ii) a fluid storage element having a longitudinal axis, the fluid storage element being in fluid communication with the at least one fluid transport element; wherein the at least one fluid transport element is bendable about an axis substantially parallel to the longitudinal axis of the fluid storage element; b) positioning the first tampon within a woman's vaginal canal while maintaining at least a portion of a major surface of the fluid transport element in contact with at least a portion of an outer surface of the fluid storage element; c) collecting a first volume of vaginal discharge while holding the first tampon in position; d) removing the first tampon from the woman's vaginal canal and subsequently disposing of the first tampon; e) providing a second tampon comprising: i) at least one fluid transport element comprising: A) a first plate having an outwardly oriented surface and an inwardly oriented surface; B) a second plate coupled to the first plate that is capable of separating from the first plate sufficiently to provide inter-plate capillary action, the second plate having a first surface disposed and maintained in facing relationship with the inwardly oriented surface of the first plate and an opposite surface; and ii) a fluid storage element having a longitudinal axis, the fluid storage element being in fluid communication with the at least one fluid transport element; wherein the at least one fluid transport element is bendable about an axis substantially parallel to the longitudinal axis of the fluid storage element; f) positioning the second tampon within a woman's vaginal canal while maintaining at least a portion of a major surface of the fluid transport element in contact with at least a portion of an outer surface of the fluid storage element; wherein the at least one fluid transport element is bendable about an axis substantially parallel to the longitudinal axis of the fluid storage element; wherein the steps of positioning and disposing of the first tampon and the steps of positioning and disposing of the second tampon occur during the period of menstruation.
 5. The method of claim 4, wherein at least one of the first and second plates comprises an apertured polymeric film.
 6. The method of claim 5, wherein the first and second plates are formed of a folded sheet of apertured polymeric film.
 7. The method of claim 4, wherein the step of positioning the first tampon within a woman's vaginal canal further comprises manipulating the first tampon to separate a distal portion of the at least one fluid transport element from the outer surface of the fluid storage element, whereby the outwardly oriented surface of the first plate and the opposite surface of the second plate contact the vaginal walls.
 8. The method of claim 4, wherein the at least one fluid transport element is wrapped convolutedly around the outer surface of the fluid storage element, and the step of positioning the first tampon within a woman's vaginal canal further comprises maintaining the at least one fluid transport element wrapped convolutedly around the outer surface of the fluid storage element. 